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Epidiolex-GW

GW Pharma’s Enormous Price for Epidiolex

By Marguerite Arnold
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Epidiolex-GW

In a fascinating early August conference call with Seeking Alpha, British-based GW Pharmaceuticals finally revealed their retail price point for CBD-based drug, Epidiolex, as it goes into distribution in the U.S.

The drug is designed for the treatment of certain kinds of childhood epilepsy – although not all kinds. Also notable of course, is that GW Pharma’s “other” drug for treatment of resistant epilepsy failed in late stage trials in Eastern Europe earlier this year. It also knocked off 5% of the price of the company’s stock.The company is estimating it has a potential patient pool of between 25,000- 30,000 patients in the U.S.

British Advocacy Over Access And Pricing

The ineffectiveness of GW Pharma’s drugs for many patients (along with the cost charged for them) was responsible for pre-empting the entire access discussion in the UK this year. The mother of an epileptic British child tried to import a personal store of cannabis oil (produced by Canadian LP Tilray) only to have it confiscated at the airport this summer. Her son ended up in the hospital shortly thereafter.

The national uproar this caused pushed forward the country’s new medical cannabis policy– indeed drug rescheduling is due to go into effect in October. Conveniently, right as Epidiolex goes on sale in the U.S. (where cannabis remains a Schedule I drug).

The company is estimating it has a potential patient pool of between 25,000- 30,000 patients in the U.S.

Price Tags and Politics

What is the price of Epidiolex? $32,500 per patient, per year. If that sounds high, the company insists it is pricing the drug to be “in line” with other drugs for this segment of the market.

The majority of this cost will not be picked up by private health insurers but rather the federal governmentActually, according to industry analysis, this is about 70% more than the price of one comparable drug (Onfi), and slightly more expensive than Banzel, the two competing (non-cannabinoid based) medications now available in the U.S. for this market.

Here is the other (widely unreported) kicker. The majority of this cost will not be picked up by private health insurers but rather the federal government, which is also not negotiating with GW Pharma about that high price  (unlike for example what is going on in Europe and the German bid).

Why the difference?

Two reasons. The first is that Epidiolex has obtained “orphan drug” status (a medication for a disease that affects fewer than 200,000 patients in the U.S.) The second is that the majority of the insurance that will be picking up this tab is Medicaid. The patient pool will be unable to afford this. As a result, the bulk of the money will remit not from private insurance companies but rather federal taxpayers. And, unlike in say, Germany, none of this is pre-negotiated in bulk.

Epidiolex-GW
What is the price of Epidiolex? $32,500 per patient, per year.

Co-payments are expected to range from $5 to $200 per month per patient after insurance (read: the government) picks up the tab. This essentially means that the company plans to base participation at first at least on a sliding scale, highly subsidized by a government that has yet to reschedule cannabis from a Schedule I in the U.S.

Creating, in other words, a new monopoly position for GW Pharmaceuticals in North America.

A Hypocrisy Both Patients And The Industry Should Fight

The sordid, underhanded politicking that has created this canna monster is hardly surprising given the current political environment in both the U.S. and the U.K. right now. The people who benefit the most from this development are not patients, or even everyday shareholders, not to mention the burgeoning legitimate North American cannabis industry, but in fact highly placed politicians (like British Prime Minister Theresa May). Philip May, the PM’s husband’s firm is the majority shareholder in GW Pharma. Her former drugs minister (with a strong stand against medical cannabis) is married to the managing director of British Sugar, the company that grows GW Pharma’s cannabis stock domestically.

So far, despite a domestic outcry over this in the UK (including rescheduling), there has been no political backlash in the United States over this announcement. Why not?

Look To Europe For A More Competitive Medical Market

This kind of pricing strategy is also a complete no go in just about every other market – including medical-only markets where GW Pharma already has a footprint.

For example, German health insurers are already complaining about this kind of pricing strategy for cannabis (see the Cannabis Report from one of the country’s largest insurers TK – out earlier this year). And this in an environment where the government, in fact, does negotiate a bulk rate for most of the drugs in the market. Currently most German cannabis patients are being given dronabinol, a synthetic form of THC which costs far less.

GW logo-2On top of this, there are also moves afoot by the German government to begin to bring the costs of medical cannabis and medicines down, dramatically. And this too will impact the market – not only in Europe, but hopefully spark a debate in every country where prices are also too high.

The currently pending German cultivation bid for medical cannabis has already set an informal “reference” price of at most 7 euros a gram (and probably will see bid competitors come in at under half that). In other words, the government wholesale price of raw, unprocessed cannabis flower if not lightly processed cannabis oil is expected to be somewhere in the neighbourhood of 3-4 euros per gram come early next year. If not, as some expect, potentially even lower than that.

Processed Cannabis Medicine vs. Whole Plant Treatment

The debate that is really raging, beyond pricing, is whether unprocessed cannabis and cannabis oil is actually “medicine.” At the moment, the status quo in the U.S. is that it is not.

GW Pharmaceuticals, in other words, a British company importing a CBD-based derivative, is the only real “medical cannabis” company in the country, per the FDA. Everyone else, at least according to this logic, is placed in the “recreational camp.” And further, hampered still, with a lack of rescheduling, that affects everyone.

If that is not an organizing issue for the American cannabis industry, still struggling with the many issues inherent in the status quo (from insurance coverage and banking to national distribution across state lines) leading up to the midterms, nothing will be.

extractiongraphic

The Four Pillars of Cannabis Processing

By Christian Sweeney
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extractiongraphic

Cannabis extraction has been used as a broad term for what can best be described as cannabis processing. A well-thought-out cannabis process goes far beyond just extraction, largely overlapping with cultivation on the front-end and product development on the back-end1. With this in mind, four pillars emerge as crucial capabilities for developing a cannabis process: Cultivation, Extraction, Analytics and Biochemistry.

The purpose and value of each pillar on their own is clear, but it is only when combined that each pillar can be optimized to provide their full capacities in a well-designed process. As such, it is best to define the goals of each pillar alone, and then explain how they synergize with each other.

At the intersection of each pillar, specific technology platforms exist that can effectively drive an innovation and discovery cycle towards the development of ideal products.Cultivation is the foundation of any horticultural process, including cannabis production. Whether the goal be to convert pigments, flavors or bioactive compounds into a usable form, a natural process should only utilize what is provided by the raw material, in this case cannabis flower. That means cultivation offers a molecular feedstock for our process, and depending on our end goals there are many requirements we may consider. These requirements start as simply as mass yield. Various metrics that can be used here include mass yield per square foot or per light. Taken further, this yield may be expressed based not only on mass, but the cannabinoid content of the plants grown. This could give rise to a metric like CBD or THC yield per square foot and may be more representative of a successful grow. Furthermore, as scientists work to learn more about how individual cannabinoids and their combinations interact with the human body, cultivators will prioritize identifying cultivars that provide unique ratios of cannabinoids and other bioactive compounds consistently. Research into the synergistic effect of terpenes with cannabinoids suggests that terpene content should be another goal of cultivation2. Finally, and most importantly, it is crucial that cultivation provide clean and safe materials downstream. This means cannabis flower free of pesticides, microbial growth, heavy metals and other contaminants.

Extraction is best described as the conversion of target molecules in cannabis raw material to a usable form. Which molecules those are depends on the goals of your product. This ranges from an extract containing only a pure, isolated cannabinoid like CBD, to an extract containing more than 100 cannabinoids and terpenes in a predictable ratio. There are countless approaches to take in terms of equipment and process optimization in this space so it is paramount to identify which is the best fit for the end-product1. While each extraction process has unique pros and cons, the tunability of supercritical carbon dioxide provides a flexibility in extraction capabilities unlike any other method. This allows the operator to use a single extractor to create extracts that meet the needs of various product applications.

Analytics provide a feedback loop at every stage of cannabis production. Analytics may include gas chromatography methods for terpene content3 or liquid chromatography methods for cannabinoids 3, 4, 5. Analytical methods should be specific, precise and accurate. In an ideal world, they can identify the compounds and their concentrations in a cannabis product. Analytics are a pillar of their own due simply to the efforts required to ensure the quality and reliability of results provided as well as ongoing optimization of methods to provide more sensitive and useful results. That said, analytics are only truly harnessed when paired with the other three pillars.

extractiongraphic
Figure 1: When harnessed together the pillars of cannabis processing provide platforms of research and investigation that drive the development of world class products.

Biochemistry can be split into two primary focuses. Plant biochemistry focuses back towards cultivation and enables a cannabis scientist to understand the complicated pathways that give rise to unique ratios of bioactive molecules in the plant. Human biochemistry centers on how those bioactive molecules interact with the human endocannabinoid system, as well as how different routes of administration may affect the pharmacokinetic delivery of those active molecules.

Each of the pillars require technical expertise and resources to build, but once established they can be a source of constant innovation. Fig. 1 above shows how each of these pillars are connected. At the intersection of each pillar, specific technology platforms exist that can effectively drive an innovation and discovery cycle towards the development of ideal products.

For example, at the intersection of analytics and cultivation I can develop raw material specifications. This sorely needed quality measure could ensure consistencies in things like cannabinoid content and terpene profiles, more critically they can ensure that the raw material to be processed is free of contamination. Additionally, analytics can provide feedback as I adjust variables in my extraction process resulting in optimized methods. Without analytics I am forced to use very rudimentary methods, such as mass yield, to monitor my process. Mass alone tells me how much crude oil is extracted, but says nothing about the purity or efficiency of my extraction process. By applying plant biochemistry to my cultivation through the use of analytics I could start hunting for specific phenotypes within cultivars that provide elevated levels of specific cannabinoids like CBC or THCV. Taken further, technologies like tissue culturing could rapidly iterate this hunting process6. Certainly, one of the most compelling aspects of cannabinoid therapeutics is the ability to harness the unique polypharmacology of various cannabis cultivars where multiple bioactive compounds are acting on multiple targets7. To eschew the more traditional “silver bullet” pharmaceutical approach a firm understanding of both human and plant biochemistry tied directly to well characterized and consistently processed extracts is required. When all of these pillars are joined effectively we can fully characterize our unique cannabis raw material with targeted cannabinoid and terpene ratios, optimize an extraction process to ensure no loss of desirable bioactive compounds, compare our extracted product back to its source and ensure we are delivering a safe, consistent, “nature identical” extract to use in products with predictable efficacies.

Using these tools, we can confidently set about the task of processing safe, reliable and well characterized cannabis extracts for the development of world class products.

[1] Sweeney, C. “Goal-Oriented Extraction Processes.” Cannabis Science and Technology, vol 1, 2018, pp 54-57.

[2] Russo, E. B. “Taming THC: potential cannabis synergy and phytocannabinoid-terpenoid entourage effects.” British Journal of Pharmacology, vol. 163, no. 7, 2011, pp. 1344–1364.

[3] Giese, Matthew W., et al. “Method for the Analysis of Cannabinoids and Terpenes in Cannabis.” Journal of AOAC International, vol. 98, no. 6, 2015, pp. 1503–1522.

[4] Gul W., et al. “Determination of 11 Cannabinoids in Biomass and Extracts of Different Varieties of Cannabis Using high-Performance Liquid Chromatography.” Journal of AOAC International, vol. 98, 2015, pp. 1523-1528.

[5] Mudge, E. M., et al. “Leaner and Greener Analysis of Cannabinoids.” Analytical and Bioanalytical Chemistry, vol. 409, 2017, pp. 3153-3163.

[6] Biros, A. G., Jones, H. “Applications for Tissue Culture in Cannabis Growing: Part 1.” Cannabis Industry Journal, 13 Apr. 2017, www.cannabisindustryjournal.com/feature_article/applications-for-tissue-culture-in-cannabis-growing-part-1/.

[7] Brodie, James S., et al. “Polypharmacology Shakes Hands with Complex Aetiopathology.” Trends in Pharmacological Sciences, vol. 36, no. 12, 2015, pp. 802–821.

Soleil control panel

IoT & Environmental Controls: urban-gro Launches Soleil Technologies Portfolio

By Aaron G. Biros
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Soleil control panel

Back in November of 2017, urban-gro announced the development of their Soleil Technologies platform, the first technology line for cannabis growers utilizing Internet-of-Things (IoT). Today, urban-gro is announcing that line is now officially available.

Soleil control panel
Screenshot of the data you’d see on the Soleil control panel

The technology portfolio, aimed at larger, commercial-scale growers, is essentially a network of monitors, sensors and controls that give cultivators real-time data on things like temperature, humidity, light, barometric pressure and other key factors. The idea of using IoT and hypersensitive monitoring is not new to horticulture, food or agriculture, but this is certainly a very new development for the cannabis growing space.

sensor
Substrate sensors, used for monitoring Ph, soil moisture & electrical conductivity.

According to Brad Nattrass, chief executive officer and co-founder of urban-gro, it’s technology like this that’ll help growers control microclimates, helping them make the minor adjustments needed to ultimately improve yield and quality. “As ROI and optimized yields become increasingly important for commercial cultivators, the need for technologies that deliver rich granular data and real-time insights becomes critical,” says Nattrass. “With the ability to comprehensively sense, monitor, and control the microclimates throughout your facility in real-time, cultivators will be able to make proactive decisions to maximize yields.”

heat map
The heat map allows you to find problem microclimates throughout the grow space.

One of the more exciting aspects of this platform is the integration of sensors, and controls with automation. With the system monitoring and controlling fertigation, lighting and climate, it can detect when conditions are not ideal, which gives a cultivator valuable insights for directing pest management or HVAC decisions, according to Dan Droller, vice president of corporate development with urban-gro. “As we add more data, for example, adding alerts for when temperatures falls or humidity spikes can tell a grower to be on the lookout for powdery mildew,” says Droller. “We saw a corner of a bench get hot in the system’s monitoring, based on predefined alerts, which told us a bench fan was broken.” Hooking up a lot of these nodes and sensors with IoT and their platform allows the grower to get real-time monitoring on the entire operation, from anywhere with an Internet connection.

soleil visuals
Figures in the system, showing temperature/time, humidity/time and light voltage

Droller says using more and more sensors creates super high-density data, which translates to being able to see a problem quickly and regroup on the fly. “Cannabis growers need to maintain ideal conditions, usually they do that with a handful of sensors right now,” says Droller. “They get peace of mind based on two or three sensors sending data points back. Our technology scales to the plant and bench level, connecting all of the aggregate data in one automated system.”

In the future, urban-gro is anticipating this will lay the groundwork for using artificial intelligence to learn when controls need to be adjusted based on the monitoring. Droller hopes to see the data from environmental conditions mapped with yield and by strain type, which could allow for ultra-precise breeding based on environmental conditions. “As we add more and more data and develop the platform further, we can deliver some elements of AI in the future, with increased controls and more scientific data,” says Droller.

The First Map of the Cannabis Genome

By Aaron G. Biros
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Sunrise Genetics, Inc., the parent company for Hempgene and Marigene, announced last week they have successfully mapped the cannabis genome. The genome map was presented at the 26th Annual Plant and Animal Genome Conference in San Diego, CA during the panel “Cannabis Genomics: Advances and Applications.”

According to CJ Schwartz, chief executive officer of Sunrise Genetics, the full genome map will allow breeders to develop strains using DNA sequence information to complement phenotyping. “In this way a breeding program can be guided by the breeder versus blindly as it is for just pheno-hunting,” says Schwartz. “At the DNA level, we can identify what version of a set of genes a plant contains, and make predictions as to the phenotype, without ever growing the plant. As we make more and more gene markers, we have more genes to track, and breeding becomes more rapid, efficient and precise.” Schwartz says this is essential for breeding stable, repeatable plants. “A commercial strain will be grown in different environments, with solid genetics, the phenotype will mostly stay true, a term we call Genetic Penetrance.”

Ancestry-painted chromosomes for marijuana Image: Chris Grassa / Sunrise Genetics

Determining a plant’s DNA can be extremely valuable and completing the map of the genome now makes this more precise. It can serve as a point of proof, according to Schwartz, providing evidence of lineage in a breeding project and confirming the uniqueness and identity of a strain. The genome map can also allow breeders to select specific genes to develop custom strains. And in addition to all that, it provides legal protection. “Knowing your plants DNA code is the first step to being able take action so no one else can protect it,” says Schwartz. “Well documented evidence in the development of a customized strains is essential to maintaining control of your plant and keeping those you distrust (big pharma) away, many of which have minimal interest in the whole plant anyhow.”

CJ Schwartz, chief executive officer of Sunrise Genetics

Schwartz says this project took them roughly 18 months to wrap up. “One of the biggest problems was just finding the right plants to grow,” says Schwartz. “In addition we used some emerging technologies and those had some challenges of their own.” According to Schwartz, a key aspect in all this was finding the right collaborators. They ended up working with CBDRx and the plant biology department at the University of Minnesota, where a DEA-licensed lab has been researching cannabis since 2002. “George Weiblen’s group at UM has been working on Cannabis for over a decade,” says Schwartz. “During that time they did repeated selfing to make highly inbred marijuana and hemp lines. The lines were instrumental in deterring the physical order of the genes.”

Ancestry-painted chromosomes for hemp Image: Chris Grassa / Sunrise Genetics

After finishing up some experiments, they expect to get the genome map published on public domain in less than a year, opening up their research to the general public and allowing breeders and growers to use their data. “This will be a very significant publication,” says Schwartz. “The genome assembly allows for the assimilation of all the currently incompatible Cannabis genome sequence datasets from academia and private companies,” says Schwartz. “Joining datasets from 1000s of strains, and from every continent, will generate an essential public resource for cannabis researchers and aficionados alike.” With a tool like this, we can discover the genes that help produce desirable traits. “This project is a major accomplishment for cannabis, bringing it on par with other important crops, providing a scientific tool to unravel the secrets of this incredibly versatile plant,” says Schwartz.

Sunrise Genetics is assisting cannabis businesses in evaluating strains and developing breeding programs, working with a number of customers currently to develop strains for many different specific traits. “We have the expertise to help select parental strains and guide the selection process at each generation using genotype and phenotype information,” says Schwartz. “Essentially we are bringing all the tools any modern plant breeder would use for improving strawberries to cannabis.”

photo of outdoor grow operation

How to Reduce Mold & Contaminants in Indoor, Greenhouse and Outdoor Grows

By Ketch DeGabrielle
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photo of outdoor grow operation

Controlling your grow environment doesn’t start when you germinate your first seeds, it starts before you build your grow. There are steps you can take that will have a significant impact on mold growth and contamination, and these will vary based on the grow environment you choose.

Below is a roadmap to where each grow environment stands in terms of mold and contamination risk, and simple steps you can take to mitigate these factors.

Outdoor

The benefits of an outdoor grow are significant – using natural sunlight to grow plants is both inexpensive and environmentally sound. However, it allows the least amount of control and makes plants susceptible to weather conditions and outdoor contaminants including dust, wind, rain and insects. Depending on humidity and precipitation levels, mold can be a big issue as well.

Outdoor growing has obvious benefits, such as natural sunlight, but may also require extra steps to prevent contamination

When selecting an outdoor area for a cannabis farm, there are two important factors to consider: location and neighboring farmland. Geographical environments and sub-climates vary and once you have purchased land, you are committed, so be sure to consider these factors prior to purchase.

While arid desert climates have abundant sunlight and long growing seasons, flat, dry lands are subject to dust-storms, flash floods and exceedingly high winds that can damage crops. Conversely, more protected areas often have high humidity and rainfall late in the season, which can create huge issues with bud rot and mold. Neighboring farms also have an impact on your grow, so be sure to find out what they cultivate, what they spray, their harvest schedule and how they run their operation. Large farming equipment kicks up a lot of contaminant-laden dust and can damage crops by displacing insects to your farm if they harvest before you. Pesticide drift is also a major issue as even tiny amounts from a neighbor’s farm can cause your crops to fail testing, depending on what state you are in.

With outdoor grow environments always at the mercy of Mother Nature, any cultivator is wise to control contamination potential on the ground. Cover soil and protect your crop by planting cover crops and laying plastic mulch on as much ground as reasonable. In many cases it makes sense to irrigate uncultivated parts of your farm just to keep dust down.

Greenhouse

Greenhouses are the future of cannabis cultivation. They allow growers to capture the full spectrum and power of the sun while lessening environmental impact and operating expenses, while still being able to precisely control the environment to grow great cannabis. With recent advancements in greenhouse technology such as automated control systems, positive pressure, geothermal heating or cooling and LED supplemental lighting, greenhouses are the future. However, older or economy greenhouses that take in unfiltered air from outside still have a medium amount of mold and contamination risk.

A greenhouse grow facility

Before building your greenhouse, study the area while taking into account climate, weather conditions and sun exposure. Excessively windy areas can blow in contaminants, and extremely hot climates make cooling the greenhouse interior a challenging and costly endeavor.

There are several simple operational tactics to reduce contaminants in a greenhouse. Add a thrip screen to keep insects out, thoroughly clean pad walls with an oxidizing agent after each cycle, and keep plants at least 10 feet from pad walls. Plan to flip the entire greenhouse at once so that you can clean the greenhouse top to bottom before your next crop. A continuous harvest in your greenhouse allows contaminants to jump from one plant to the next and reduces the ability to control your environment and eliminate problems at the end of a cycle. Lastly, open shade curtains slowly in the morning. This prevents temperature inversion and condensation, which can cause water drops to fall from the ceiling and transfer contaminants onto plants below.

Indoor

An indoor environment offers ultimate control to any grow operation. Cultivators can grow high-quality cannabis with the smallest potential for yeast and mold growth. Unfortunately, indoor environments are extremely expensive, inefficient and environmentally costly.

Talltrees
An indoor cannabis operation set up (Image: Tall Trees LED Company)

With indoor grow environments, keeping mold and contaminants at bay comes down to following a regimented plan that keeps all grow aspects clean and in order. To keep your grow environment clean, change HVAC filters multiple times a month. It’s also important to install HEPA filters and UV lights in HVAC systems to further reduce contamination threats. Clearly mark air returns if they are near the ground and keep those areas free of clutter. They are the lungs of your grow. Also, stop using brooms in the grow space. They stir up a lot of contaminants that have settled to the floor. Instead, use HEPA filter backpack vacuums or install a central vacuum system. Set up a “dirty room” for anything messy on a separate HVAC system, and be sure to thoroughly clean pots after every harvest cycle.

Learn more about reducing mold and contaminants in an indoor or greenhouse grow in another article from our series: 10 Ways to Reduce Mold in Your Grow.

10 Ways to Reduce Mold in Your Grow

By Ketch DeGabrielle
3 Comments

Regardless of whether your grow is indoor or in a greenhouse, mold is a factor that all cultivators must consider.

Photo credit: Steep Hill- a petri dish of mold growth from tested cannabis

After weeks of careful tending, pruning and watering to encourage a strong harvest, all cultivators are looking to sell their crop for the highest market value. A high mold presence, measured through a total yeast and mold count (TYMC), can cause a change of plans by decreasing crop value. But it doesn’t have to.

There are simple steps that any cultivator can take that will greatly eliminate the risk of mold in a grow. Below are some basic best practices to incorporate into your operation to reduce contaminants and mold growth:

  1. Isolate dirty tasks. If you are cleaning pots, filling pots or scrubbing trimming scissors, keep these and other dirty tasks away from grow and process areas. Dirty tasks can contaminate the grow area and encourage mold growth. Set up a “dirty room” that does not share heating, ventilation and air conditioning with clean areas.
  2. Compartmentalize the grow space. Mold can launch spores at speeds up to 55 miles per hour up to eight feet away without any air current. For this reason, if mold growth begins, it can become a huge problem very quickly. Isolate or remove a problem as soon as it is discovered- better to toss a plant than to risk your crop.
  3. No drinks or food allowed. Any drinks or food, with the exception of water, are completely off limits in a grow space. If one of your employees drops a soda on the ground, the sugars in the soda provide food for mold and yeast to grow. You’d be surprised how much damage a capful of soda or the crust of a sandwich can do.
  4. Empty all trash daily. Limiting contaminants in turn limits the potential for issues. This is an easy way to keep your grow clean and sterile.
  5. Axe the brooms. While a broom may seem like the perfect way to clean the floor, it is one of the fastest ways to stir up dirt, dust, spores and contaminants, and spread them everywhere. Replace your brooms with hepa filter backpack vacuums, but be sure that they are always emptied outside at the end of the work day.
  6. No standing water or high humidity. Mold needs water to grow, therefore standing water or high humidity levels gives mold the sustenance to sporulate. Pests also proliferate with water. Remove standing water and keep the humidity level as low as possible without detriment to your plants.
  7. Require coveralls for all employees. Your employee may love his favorite jean jacket, but the odds are that it hasn’t been cleaned in months and is covered with mold spores. Clean clothing for your staff is a must. Provide coveralls that are washed at least once a week if not daily.
  8. Keep things clean. A clean and organized grow area will have a huge impact on mold growth. Clean pots with oxidate, mop floors with oxidate every week, keep the areas in front of air returns clean and clutter-free, and clean floor drains regularly. The entire grow and everything in it should be scrubbed top to bottom after each harvest.
  9. Keep it cool. Keep curing areas cool and storage areas cold where possible. The ideal temperature for a curing area is roughly 60 degrees and under 32 degrees for a storage area. Just like food, the lower the temperature, the better it keeps. High temperature increases all molecular and biological activity, which causes things to deteriorate faster than at cooler temperatures. However, curing temperature is a function of water activity more than anything.
  10. Be Careful With Beneficials. Beneficial insects certainly have their place in the grow environment. However, if you have a problem with mold on only a small percentage of plants, any insect can act as a carrier for spores and exacerbate the problem. By the same token, pests spread mold more effectively than beneficials because they produce rapidly, where beneficials die if there aren’t pests for them to eat. It is best to use beneficials early in the cycle and only when necessary.

Sunrise Genetics Partners With RPC, Begins Genetic Testing in Canada

By Aaron G. Biros
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Sunrise Genetics, Inc., the parent company of Marigene and Hempgene, announced their partnership with New Brunswick Research & Productivity Council (RPC) this week, according to a press release. The company has been working in the United States for a few years now doing genomic sequencing and genetic research with headquarters based in Fort Collins, CO. This new partnership, compliant with Health Canada sample submission requirements, allows Canadian growers to submit plants for DNA extraction and genomic sequencing.

Sunrise Genetics researches different cannabis cultivars in the areas of target improvement of desired traits, accelerated breeding and expanding the knowledge base of cannabis genetics. One area they have been working on is genetic plant identification, which uses the plant’s DNA and modern genomics to create authentic, reproducible, commercial-ready strains.

Matt Gibbs, president of Sunrise Genetics, says he is very excited to get working on cannabis DNA testing in Canada. “RPC has a long track record of leadership in analytical services, especially as it relates to DNA and forensic work, giving Canadian growers their first real option to submit their plant samples for DNA extraction through proper legal channels,” says Gibbs. “The option to pursue genomic research on cannabis is now at Canadian cultivator’s fingertips.”

Canada’s massive new cannabis industry, which now has legal recreational and medical use, sales and cultivation, previously has not had many options for genetic testing. Using their genetic testing capabilities, they hope this partnership will better help Canadian cultivators easily apply genomic testing for improved plant development. “I’m looking forward to working with more Canadian cultivators and breeders; the opportunity to apply genomics to plant improvement is a win-win for customers seeking transparency about their Cannabis product and producers seeking customer retention through ‘best-in-class’ cannabis and protectable plant varieties,” says Gibbs. The partnership also ensures samples will follow the required submission process for analytical testing, but adding the service option of genetic testing so growers can find out more about their plants beyond the regular gamut of tests.

RPC is a New Brunswick provincial research organization (PRO), a research and technology organization (RTO) that offers R&D testing and technical services. With 130 scientists, engineers and technologists, RPC offers a wide variety of testing services, including air quality, analytical chemistry of cannabis, material testing and a large variety of pilot facilities for manufacturing research and development.

They have over 100 accreditations and certifications including an ISO 17025 scope from the Standards Council of Canada (SCC) and is ISO 9001:2008 certified. This genetic testing service for cannabis plants is the latest development in their repertoire of services. “This service builds on RPC’s established genetic strengths and complements the services we are currently offering the cannabis industry,” says Eric Cook, chief executive officer of RPC.

Total Yeast & Mold Count: What Cultivators & Business Owners Need to Know

By Parastoo Yaghmaee, PhD
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Editor’s note: This article should serve as a foundation of knowledge for yeast and mold in cannabis. Beginning in January 2018, we will publish a series of articles focused entirely on yeast and mold, discussing topics such as TYMC testing, preventing yeast and mold in cultivation and treatment methods to reduce yeast and mold.

Cannabis stakeholders, including cultivators, extractors, brokers, distributors and consumers, have been active in the shadows for decades. With the legalization of recreational adult use in several states, and more on the way, safety of the distributed product is one of the main concerns for regulators and the public. Currently, Colorado1, Nevada and Canada2 require total yeast and mold count (TYMC) compliance testing to evaluate whether or not cannabis is safe for human consumption. As the cannabis industry matures, it is likely that TYMC or other stringent testing for yeast and mold will be adopted in the increasingly regulated medical and recreational markets.

The goal of this article is to provide general information on yeast and mold, and to explain why TYMC is an important indicator in determining cannabis safety.

Yeast & Mold

Photo credit: Steep Hill- a petri dish of mold growth from tested cannabis

Yeast and mold are members of the fungi family. Fungus, widespread in nature, can be found in the air, water, soil, vegetation and in decaying matter. The types of fungus found in different geographic regions vary based upon humidity, soil and other environmental conditions. In general, fungi can grow in a wide range of pH environments and temperatures, and can survive in harsh conditions that bacteria cannot. They are not able to produce their own food like plants, and survive by breaking down material from their surroundings into nutrients. Mold cannot thrive in an environment with limited oxygen, while yeast is able to grow with or without oxygen. Most molds, if grown for a long enough period, can be detected visually, while yeast growth is usually detected by off-flavor and fermentation.

Due to their versatility, it is rare to find a place or surface that is naturally free of fungi or their spores. Damp conditions, poor air quality and darker areas are inviting environments for yeast and mold growth.

Cannabis plants are grown in both indoor and outdoor conditions. Plants grown outdoors are exposed to wider ranges and larger populations of fungal species compared to indoor plants. However, factors such as improper watering, the type of soil and fertilizer and poor air circulation can all increase the chance of mold growth in indoor environments. Moreover, secondary contamination is a prevalent risk from human handling during harvest and trimming for both indoor and outdoor-grown cannabis. If humidity and temperature levels of drying and curing rooms are not carefully controlled, the final product could also easily develop fungi or their growth by-product.

 What is TYMC?

TYMC, or total yeast and mold count, is the number of colony forming units present per gram of product (CFU/g). A colony forming unit is the scientific means of counting and reporting the population of live bacteria or yeast and mold in a product. To determine the count, the cannabis sample is plated on a petri dish which is then incubated at a specific temperature for three to five days. During this time, the yeast and mold present will grow and reproduce. Each colony, which represents an individual or a group of yeast and mold, produces one spot on the petri dish. Each spot is considered one colony forming unit.

Why is TYMC Measured?

TYMC is an indicator of the overall cleanliness of the product’s life cycle: growing environment, processing conditions, material handling and storage facilities. Mold by itself is not considered “bad,” but having a high mold count, as measured by TYMC, is alarming and could be detrimental to both consumers and cultivators. 

Aspergillus species niger
Photo: Carlos de Paz, Flickr

The vast majority of mold and yeast present in the environment are indeed harmless, and even useful to humans. Some fungi are used commercially in production of fermented food, industrial alcohol, biodegradation of waste material and the production of antibiotics and enzymes, such as penicillin and proteases. However, certain fungi cause food spoilage and the production of mycotoxin, a fungal growth by-product that is toxic to humans and animals. Humans absorb mycotoxins through inhalation, skin contact and ingestion. Unfortunately, mycotoxins are very stable and withstand both freezing and cooking temperatures. One way to reduce mycotoxin levels in a product is to have a low TYMC.

Aspergillus flavus on culture.
Photo: Iqbal Osman, Flickr

Yeast and mold have been found to be prevalent in cannabis in both current and previous case studies. In a 2017 UC Davis study, 20 marijuana samples obtained from Northern California dispensaries were found to contain several yeast and mold species, including Cryptococcus, Mucor, Aspergillus fumigatus, Aspergillus niger, and Aspergillus flavus.3 The same results were reported in 1983, when marijuana samples collected from 14 cannabis smokers were analyzed. All of the above mold species in the 2017 study were present in 13 out of 14 marijuana samples.4

Aspergillus species niger, flavus, and fumigatus are known for aflatoxin production, a type of dangerous mycotoxin that can be lethal.5 Once a patient smokes and/or ingests cannabis with mold, the toxins and/or spores can thrive inside the lungs and body.6, 7 There are documented fatalities and complications in immunocompromised patients smoking cannabis with mold, including patients with HIV and other autoimmune diseases, as well as the elderly.8, 9, 10, 11

For this reason, regulations exist to limit the allowable TYMC counts for purposes of protecting consumer safety. At the time of writing this article, the acceptable limit for TYMC in cannabis plant material in Colorado, Nevada and Canada is ≤10,000 CFU/g. Washington state requires a mycotoxin test.12 California is looking into testing for specific Aspergillus species as a part of their requirement. As the cannabis industry continues to grow and advance, it is likely that additional states will adopt some form of TYMC testing into their regulatory testing requirements.

References:

  1. https://www.colorado.gov/pacific/sites/default/files/Complete%20Retail%20Marijuana%20Rules%20as%20of%20April%2014%202017.pdf
  2. http://laws-lois.justice.gc.ca/eng/acts/f-27/
  3. https://www.ucdmc.ucdavis.edu/publish/news/newsroom/11791
  4. Kagen SL, Kurup VP, Sohnle PG, Fink JN. 1983. Marijuana smoking and fungal sensitization. Journal of Allergy & Clinical Immunology. 71(4): 389-393.
  5. Centre for Disease control and prevention. 2004 Outbreak of Aflatoxin Poisoning – Eastern and central provinces, Kenya, Jan – July 2004. Morbidity and mortality weekly report.. Sep 3, 2004: 53(34): 790-793
  6. Cescon DW, Page AV, Richardson S, Moore MJ, Boerner S, Gold WL. 2008. Invasive pulmonary Aspergillosis associated with marijuana use in a man with colorectal cancer. Diagnosis in Oncology. 26(13): 2214-2215.
  7. Szyper-Kravits M, Lang R, Manor Y, Lahav M. 2001 Early invasive pulmonary aspergillosis in a leukemia patient linked to aspergillus contaminated marijuana smoking. Leukemia Lymphoma 42(6): 1433 – 1437.
  8. Verweii PE, Kerremans JJ, Voss A, F.G. Meis M. 2000. Fungal contamination of Tobacco and Marijuana. JAMA 2000 284(22): 2875.
  9. Ruchlemer R, Amit-Kohn M, Raveh D, Hanus L. 2015. Inhaled medicinal cannabis and the immunocompromised patient. Support Care Cancer. 23(3):819-822.
  10. McPartland JM, Pruitt PL. 1997. Medical Marijuana and its use by the immunocompromised. Alternative Therapies in Health and Medicine. 3 (3): 39-45.
  11. Hamadeh R, Ardehali A, Locksley RM, York MK. 1983. Fatal aspergillosis associated with smoking contaminated marijuana, in a marrow transplant recipient. Chest. 94(2): 432-433.
  12. http://apps.leg.wa.gov/wac/default.aspx?cite=314-55-102
Soapbox

Medical Cannabis & The Vernacular Of Maturity

By RJ Starr
1 Comment

Marijuana. Mary Jane. Pot. Reefer. Ganja. Weed. Joint. Grass.

The variety of terms used to describe cannabis are as diverse as the potentials of the plant itself – as well as the opinions of its proper nomenclature. A quick web search came up with a number of articles about how we should refer to cannabis, and opinions can be just as annoying and stinging as mosquitoes in the Everglades at the peak of season. Each of these words has an origin with which, having all the facts, you might not choose to align yourself. Words matter, and whether born from racism, xenophobia, or just plain ignorance, one will never go wrong following one simple piece of advice: “Never use a word or a phrase unless you know its meaning.” That said, it is not my intention here to add another opinion, but rather to present the topic from a different vantage. I’ll leave it up to you to decide whether or not it is worth your while to learn what you are saying, and in so doing, empower yourself to consider your audience as you consider your slang, just as you would with any other word.

The legalized cannabis industry has opened a plethora of professional opportunities. Thoughtfully considered, these opportunities can lead to new heights of professional accomplishment and financial earning capability. For those with the good fortune to have such opportunity in legalized cannabis, congratulations! You are a member of a very small group of pioneers who have the potential to shape an entire industry (remember that what Henry Ford did by creating the assembly line brought benefit, not just to the automotive industry, but to all industry.)

In this industry we are not just creating medical cannabis dispensaries, cultivation and processing facilities, we are creating new ideas and platforms for compliance, security, financial planning, quality assurance, botany, agriculture, sustainability, packaging, retail, inventory control, human capital – the list is as endless as the imagination – with the potential to influence capacity in every aspect of all types of industry, around the world. In the course of your career as a cannabis professional you will have a chance to interact with legal and healthcare professionals, legislators, regulators and investors. You may attend high profile events, hobnob with those who inspire social change and exchange dialog with thought leaders from all walks of life. As you represent your particular cannabis company, you will recognize that you also represent yourself, and in that very recognition will your thoughtfully chosen vernacular reveal your personal level of professionalism, eloquence and dignity; and irrespective of what, or from whom, any opinion originates, these core values are irreplaceable. Simply put, adults speak like adults.

A colleague reflected that we are not winning a long and drawn out struggle to divest ourselves from outdated prohibitions against the use of medical cannabis because of the words we are using, but because of education. While I agree with that assessment, the use of slang in professional discourse has a tendency to discredit the speaker and narrow the audience receptive to his message. As the scientific community and cannabis industry continues to re-educate society, our efforts will be bolstered by reaching as broad an audience as possible. Education presented professionally, eloquently, and with maturity engenders respect, goodwill and understanding. And that makes for fertile ground upon which to plant new ideas.